Edwards Lifesciences Staff Electronics Test Engineer - Critical Care in Irvine, California
The Staff Electronics Test Engineer is an exciting opportunity for you to collaborate on projects, products, and initiatives in support of Edwards Lifesciences’ Advanced Hemodynamic monitoring systems. You will play a key role for the Electronics business as we expand our product service and repair capabilities globally and grow the service business. We are seeking a talented electronics engineer with a strong background in test engineering, developing test requirements and the ability to work with outside vendors for test development.
In this role you will:
Develop manufacturing/service test specifications for use by vendors in the development of test platforms for production and service.
Work collaboratively with external vendors in the development of test platforms.
Document test process/procedures with instructions, forms, standards and specifications as necessary, showing a working knowledge of medical device requirements and testing lifecycles.
Provide guidance, oversight, training, and approval in the execution of validation of the testers and test methods to our global service centers and contract manufacturers (IQ,OQ,PQ).
Select and procure failure analysis equipment for the Edwards onsite failure analysis lab. Setup, operate, and maintain the laboratory for optimal Failure Analysis and Ongoing Reliability Testing (ORT) availability.
Contribute to corrective actions in response to complaint data; determine whether design modifications would contribute to complaint/non-conformance reductions.
Contribution of testability/serviceability assessments from concept, development, and commercialization of products.
Provide metrics dashboard with in-process data reflecting operation yields, rolled throughput yields, defect rates, and defect locations. Analyze the data against targets and complete root cause analysis and corrective action for those areas where target to actual measurements are unfavorable.
Develop test strategies for new products and facilitate sustaining activities in the product testing areas of both new products and legacy products.
Participate in Lean and Six Sigma projects to improve products, processes, or systems used in the operations area.
Use technical principles, problem solving skills, and data analysis to support and problem-solve for production and service at remote sites and third party suppliers through a robust supplier interface.
Establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis).
10% International and Domestic travel to visit vendors and service center sites.
Required Education / Experience / Skills:
A Bachelors Degree in a related engineering discipline is required. An Electronics or Computer Science Engineering degree is highly preferred.
A minimum of 5 years of test engineering experience within a medical device, electronics manufacturing environment is required. Medical device contract manufacturing experience is a plus.
Demonstrated ability to understand electronics schematics, electronics component data sheets, custom mechanical drawings, and software controlled systems.
Direct experience with electronics PCBA and device level build and test process. Experience working with board level and device level test equipment.
Strong communication skills for presentations, written documents, and verbal interaction with internal and external customers. Ability to communicate to senior management, peer levels, and subordinate levels of the organization in a clear, concise, and accurate manner.
Familiarity with medical device regulations and governance documents (ISO13485, CFR820, etc).
Familiarity with International Standards (IEC60601, etc).
Experience writing and executing protocols for validation of tools, fixtures, equipment, and process.
Capable of analyzing and solving complex problems through innovative thought and experience.
Capable of making decisions based on data, analysis, and problem solving methods (ex: DMAIC) then acting quickly to deploy the desired option.
Experience working with suppliers of electronics components, subassemblies, and finished devices.
Ability to perform root cause analysis and recommendations for non-conforming products.
Motivation and ability to lead the test elements of a project.
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Staff Electronics Test Engineer - Critical Care Location: USA-USA-California - Irvine Job Number: 009187